WHAT DOES A CLINICAL RESEARCH COORDINATOR DO?
Published: May 23, 2025 – The Clinical Research Coordinator coordinates and manages clinical research protocols in oncology, ensuring compliance with regulatory standards and Institutional Review Board (IRB) requirements. This position oversees patient recruitment, consent, data collection, and interaction with investigators, sponsors, and regulatory bodies throughout the study lifecycle. The coordinator also performs study-related procedures and maintains accurate documentation while educating healthcare staff and supporting audit readiness.
A Review of Professional Skills and Functions for Clinical Research Coordinator
1. Clinical Research Coordinator Functions
- Patient Scheduling: Assist with initial patient scheduling and first visits as trials begin at the clinic.
- Documentation Management: Maintain and manage all trial-specific source documentation
- Patient Coordination: See patients and assist in the completion of research visits
- Data Management: Manage the collection, recording, reporting, and storage of study-related data, investigational product, and study equipment
- Regulatory Communication: Communicate and work directly with the CRO and Sponsor representatives during pre-study, IMV, and site closure, adhering to site-specific standard operating procedures, local and federal regulations.
2. Clinical Research Coordinator Overview
- Reporting Structure: Reports to the Director of Clinical Trials or the Clinical Research Nurse Lead
- Team Collaboration: Collaborates with departmental leadership and research staff in the coordination of all aspects of clinical research studies.
- Patient Recruitment: Responsible for patient screening and recruitment, coordination of care for the research patient, protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB).
- Oncology Coordination: Coordinates studies in Oncology therapeutic areas.
- Protocol Management: Responsible for the complete coordination of assigned clinical research protocols from national research agencies and pharmaceutical corporations
- Patient Screening: Screens patients for study participation, e.g., reviews medical record, collaborates with medical and research staff, etc., and procures informed consent.
- Documentation Accuracy: Maintains accurate and thorough documentation on all source documents and case report forms (CRFs) for each study patient. Enters data. Resolves all patient queries.
- Stakeholder Communication: Maintains communication with investigators/researchers, patients, internal and external collaborators (e.g., consulting physicians, Monitors), sponsors, federal regulatory agencies, and other involved parties
- Study Meetings: Participates in investigator, coordinator, or study initiation meetings accordingly.
- Monitoring Coordination: Coordinates and participates in monitoring visits/audits with regulatory agencies or sponsors.
- Regulatory Training: Maintains current regulatory (GCP, HSR) and study-specific required training.
- IRB Submissions: Prepares and submits all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB).
- Staff Education: Educates hospital staff about protocols through in-services, written materials, and one-on-one interaction, for each study and each patient, and for general marketing.
- Schedule Flexibility: Demonstrates flexibility in daily routine and effectively accommodates the needs of the job (e.g., early or late patient enrollment).
- Clinical Procedures: Performs procedures including EKG, Phlebotomy, blood and body fluid sampling, packing and shipment of human samples, body measurements and examinations within the scope of practice and training, consistent with clinic and study-specific policies/procedures and scope of care under the guidance of the supervisor.
- Compliance Responsibilities: Fulfills all compliance responsibilities related to the position.
3. Clinical Research Nurse Coordinator Tasks
- Subject Recruitment: Recruits, interviews, and obtains informed consent from prospective subjects for entrance into clinical trials and studies.
- Lab Coordination: Coordinates appropriate laboratory tests and other procedures for subjects participating in studies, including drawing blood or the collection of other samples.
- Pharmacy Coordination: Coordinates with Investigational Pharmacy for subjects to receive required drugs.
- Billing Communication: Communicates with Sponsored Programs Administration to ensure proper management of charges and billing.
- IRB Submission: Coordinates and submits IRB protocols, reports, revisions, updates, and approvals.
- Data Recording: Records appropriate clinical and laboratory data on forms provided by the principal investigators, the federal government, and/or industry sponsors.
- Stakeholder Communication: Communicates with study sponsors, federal agencies, principal investigators, and sub-investigators about research projects.
- Resource Provision: Provides resources for staff, patients, families, and the community regarding research.
- Site Travel: Travels to clinical research sites, hospitals, physician offices, and facilities within the System.
4. Clinical Research Associate Job Summary
- Study Planning: Plan and conduct clinical studies applying diabetes technology
- Data Analysis: Data analysis and statistics
- Algorithm Development: Contribute to the development of new control algorithms for automated delivery of insulin and other glucose-regulatory drugs within an interdisciplinary framework (clinicians and engineers).
- Grant Writing: Write and submit grants and clinical research papers independently, and prepare and give oral/poster presentations at international conferences
- Idea Generation: Come up with original ideas and work towards proving them and ultimately getting them funded through the grant submission process
5. Clinical Research Associate Roles and Details
- Site Monitoring: Identify, select, and monitor performance of investigational sites for clinical studies.
- Regulatory Compliance: Ensure studies are carried out according to the study protocol, SOPs, and ICH/GCP regulations and study-specific manuals and procedures.
- Document Development: Write, contribute and review clinical protocols, amendments, informed consent forms, study guides, case report forms, IMP release package and any other clinical research-related documents.
- Study Tracking: Track and report on the progress of the study, including site activation, patient enrollment, and monitoring visits.
- Sponsor Representation: Act as Sponsor representative for study sites during study visits
- Staff Training: Oversee the proper training of staff members who are working on the study
- TMF Management: Responsible for TMF maintenance.
- Study Support: Contribute to all other study activities